LIGHT AI PROVIDES QUICKSCAN™ STREP A PRODUCT DEVELOPMENT UPDATE

VANCOUVER, BC, Oct. 2, 2026 /CNW/ -- Light AI Inc. ("Light AI" or the "Company") (Cboe CA: ALGO; (FSE: 0HC) (OTCQB: OHCFF) today announced that it will keep its QuickScan™ Strep A software-as-a-medical-device ("SaMD") in controlled product development and continue its hold on related clinical activities.

Management made this decision following a preliminary product, quality and verification and validation ("V&V") assessment that identified gaps in the objective evidence currently available to substantiate performance of the complete QuickScan™ Strep A system across its intended-use population and use environment. The assessment includes machine-learning development and validation evidence, datasets, image acquisition and processing, software and system V&V, design controls, usability, cybersecurity and supporting quality-system documentation.

As a result, the Company will not resume external clinical validation or advance toward a U.S. Food and Drug Administration ("FDA") submission until the product configuration and supporting objective evidence establish readiness for clinical use.

Action Plan

The Company will undertake a structured technical and quality action plan that will include:

• continuing the hold on its New Zealand feasibility activities and planned U.S. clinical study;
• conducting an independent robustness assessment of the existing machine-learning model and supporting datasets;
• determining whether the existing model can be remediated and/or retrained or whether redevelopment is required;
• continuing to evaluate controlled imaging alternatives to the current smartphone-based image-acquisition approach; and
• completing the required design-control, quality-system and system-level V&V activities.

The preliminary assessment has not reached a conclusion on the underlying technology's ability to achieve its target performance or on whether the existing machine-learning model can be retrained rather than redeveloped; those questions will be addressed through the independent robustness assessment described above. Management has concluded that the Company does not currently have sufficient objective evidence to rely upon the existing product configuration and validation package for further clinical deployment or advancement toward an FDA submission without additional development, remediation and V&V.

Expected Implications

The timing of the Company's previously contemplated U.S. clinical and FDA regulatory activities is being reassessed. The Company will not provide a revised timetable until the relevant development, remediation and V&V work has progressed sufficiently to support a reliable assessment of next steps.

"Patient safety, product performance and objective scientific evidence are the foundation of our development program," said John R. Luna, Chief Executive Officer and Director of Light AI. "Our review identified gaps in the evidence supporting the performance of the complete QuickScan™ system, and we are addressing them directly. Before we resume clinical studies, we intend to complete the development, design-control and validation work necessary to establish that the product performs as intended across its intended-use population and use environment. This is a setback in timing, but doing this work now is the right path to building a product that clinicians and patients can rely on."

The Company's Health Canada Class II medical device license, as disclosed in the Company's news release dated August 12, 2026, remains in effect. The Company is assessing the findings of its review and any resulting regulatory obligations in consultation with its regulatory advisors.

The Company expects to provide its next update when it has reached material milestones or decisions regarding the machine-learning assessment, imaging architecture, remediation program, clinical activities or regulatory strategy.

About Light AI Inc. (CBOE CA: ALGO / FSE: 0HC / OTCQB: OHCFF)

Light AI Inc. is a healthcare technology company focused on developing artificial intelligence-powered SaMD solutions designed to support rapid, accessible clinical assessment at the point of care.

The Company's core technology, Light AI QuickScan™, is a device-agnostic software platform that applies proprietary artificial intelligence and machine learning algorithms to medical images to provide healthcare professionals with actionable clinical information within seconds. The QuickScan™ platform is designed to operate across compatible imaging and computing hardware, providing flexibility for integration into a range of healthcare devices, clinical workflows and care settings without dependence on a single proprietary hardware platform.

ON BEHALF OF THE COMPANY

"John R. Luna"
Chief Executive Officer

For more information, please contact the Company at [email protected] or visit https://light.ai/.

Website: https://light.ai/
LinkedIn: LinkedIn/company/Light AI
X (Formerly Twitter): @lightaihealth

Forward-Looking Information:

This news release contains "forward-looking statements" and "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "anticipate," "believe," "expect," "estimate," "intend," "plan," "project," "target," "potential," "will," "may," "could," "should," "would," and similar expressions.  These forward looking statements include the Company's expectations regarding its anticipated technical and quality remediation program, including the assessment and the evaluation of the underlying technology and the existing machine-learning model, the timing and resumption of external clinical validation activities and advancement toward an FDA submission, the Company's regulatory strategy and potential regulatory obligations, and the Company's business strategy, development plans, and market opportunities.  Forward looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks with the Company's ability to successfully execute its business plans, the Company's ability to raise additional capital, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, the QuickScan™ platform does not perform as anticipated in clinical or actual patient settings, risks associated with the development, validation, and ongoing performance of artificial intelligence and machine learning algorithms, including algorithmic bias, data quality issues, and cybersecurity vulnerabilities, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, and other risks detailed from time to time in the Company's documents filed under its SEDAR+ profile at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any such forward-looking information. Further, any forward-looking statement speaks only as of the date on which such statement is made. New factors emerge from time to time, and it is not possible for the Company's management to predict all of such factors and to assess in advance the impact of each such factor on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  The Company does not undertake any obligation to update any forward-looking information to reflect information, events, results, circumstances or otherwise after the date hereof or to reflect the occurrence of unanticipated events, except as required by law including securities laws.

SOURCE Light AI Inc.

For further information: John R. Luna, Chief Executive Officer, Telephone: [phone], Email: [email protected]